BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD GRAY 16GA X 1.16IN

    MDR report key: 12028500 · Received June 18, 2021

    Report

    Report Number
    1710034-2021-00514
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 24, 2021
    Report Date
    August 11, 2021
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/1/2021. H.6. INVESTIGATION: BD RECEIVED A 16 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 0111316 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED A V-SHAPED CUT NEAR THE CATHETER TIP INDICATIVE OF THE NEEDLE PIERCING THROUGH THE CATHETER TUBING. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT OF THE NEEDLE PIERCING THROUGH THE CATHETER TUBING. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THIS DEFECT COULD HAVE ORIGINATED DURING THE MANUFACTURING PROCESS OR IN THE CLINICAL SETTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD GRAY 16GA X 1.16IN CATHETER TIP OPENED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER'S TIP HAS OPENED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOGUARD GRAY 16GA X 1.16IN CATHETER TIP OPENED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER'S TIP HAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920444 INSYTE AUTOGUARD GRAY 16GA X 1.16IN INTRAVASCULAR CATHETER FOZ 0111316

    Patients

    Seq Age Sex Outcome Treatment
    1